Zhu H - Search Results

1

Shortened Positive and Negative Symptom Scale as an Alternate Clinical Endpoint for Acute Schizophrenia Trials: Analysis from the US Food & Drug Administration.

Gopalakrishnan M, Farchione T, Mathis M, Zhu H, Mehta M, Uppoor R, Younis I. Gopalakrishnan M, et al. Among authors: zhu h. Psychiatr Res Clin Pract. 2020 Nov 6;3(1):38-45. doi: 10.1176/appi.prcp.20200003. eCollection 2021 Spring. Psychiatr Res Clin Pract. 2020. PMID: 36101554 Free PMC article.

2

An integrated clinical pharmacology approach for deriving dosing recommendations in a regulatory setting: review of recent cases in psychiatry drugs.

Younis IR, Rogers H, Zhang H, Zhu H, Uppoor RS, Mehta MU. Younis IR, et al. Among authors: zhu h. J Clin Pharmacol. 2013 Oct;53(10):1005-9. doi: 10.1002/jcph.118. Epub 2013 Jul 10. J Clin Pharmacol. 2013. PMID: 23842865 Review.

3

The US Food and Drug Administration's perspective on the new antidepressant vortioxetine.

Zhang J, Mathis MV, Sellers JW, Kordzakhia G, Jackson AJ, Dow A, Yang P, Fossom L, Zhu H, Patel H, Unger EF, Temple RJ. Zhang J, et al. Among authors: zhu h. J Clin Psychiatry. 2015 Jan;76(1):8-14. doi: 10.4088/JCP.14r09164. J Clin Psychiatry. 2015. PMID: 25562777

4

Exposure-response analyses of blood pressure and heart rate changes for methylphenidate in healthy adults.

Li L, Wang Y, Uppoor RS, Mehta MU, Farchione T, Mathis MV, Zhu H. Li L, et al. Among authors: zhu h. J Pharmacokinet Pharmacodyn. 2017 Jun;44(3):245-262. doi: 10.1007/s10928-017-9513-5. Epub 2017 Feb 18. J Pharmacokinet Pharmacodyn. 2017. PMID: 28214989

5

A Quantitative Justification of Similarity in Placebo Response Between Adults and Adolescents With Acute Exacerbation of Schizophrenia in Clinical Trials.

Kalaria SN, Zhu H, Farchione TR, Mathis MV, Gopalakrishnan M, Uppoor R, Mehta M, Younis I. Kalaria SN, et al. Among authors: zhu h. Clin Pharmacol Ther. 2019 Nov;106(5):1046-1055. doi: 10.1002/cpt.1501. Epub 2019 Jul 3. Clin Pharmacol Ther. 2019. PMID: 31069784

6

A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH.

Zhu H, Chen X, Ahmed M, Wang Y, Liu Q, Uppoor RS, Kuemmel C, Mehta M. Zhu H, et al. Clin Transl Sci. 2019 Nov;12(6):564-572. doi: 10.1111/cts.12658. Epub 2019 Aug 16. Clin Transl Sci. 2019. PMID: 31169344 Free PMC article.

7

Assessment of Similarity in Antipsychotic Exposure-Response Relationships in Clinical Trials Between Adults and Adolescents With Acute Exacerbation of Schizophrenia.

Kalaria SN, Farchione TR, Mathis MV, Gopalakrishnan M, Younis I, Uppoor R, Mehta M, Wang Y, Zhu H. Kalaria SN, et al. Among authors: zhu h. J Clin Pharmacol. 2020 Jul;60(7):848-859. doi: 10.1002/jcph.1580. Epub 2020 Jan 28. J Clin Pharmacol. 2020. PMID: 31994186

8

Exposure-Response Assessment in Pediatric Drug Development Studies Submitted to the US Food and Drug Administration.

Zhang Y, Wang Y, Khurana M, Sachs HC, Zhu H, Burckart GJ, Alexander J, Yao LP, Wang J. Zhang Y, et al. Among authors: zhu h. Clin Pharmacol Ther. 2020 Jul;108(1):90-98. doi: 10.1002/cpt.1809. Epub 2020 Mar 16. Clin Pharmacol Ther. 2020. PMID: 32030741

9

The Trend of Increasing Placebo Response and Decreasing Treatment Effect in Schizophrenia Trials Continues: An Update From the US Food and Drug Administration.

Gopalakrishnan M, Zhu H, Farchione TR, Mathis M, Mehta M, Uppoor R, Younis I. Gopalakrishnan M, et al. Among authors: zhu h. J Clin Psychiatry. 2020 Mar 3;81(2):19r12960. doi: 10.4088/JCP.19r12960. J Clin Psychiatry. 2020. PMID: 32141721

10

Association of End Point Definition and Randomized Clinical Trial Duration in Clinical Trials of Schizophrenia Medications.

Younis IR, Gopalakrishnan M, Mathis M, Mehta M, Uppoor R, Zhu H, Farchione T. Younis IR, et al. Among authors: zhu h. JAMA Psychiatry. 2020 Oct 1;77(10):1064-1071. doi: 10.1001/jamapsychiatry.2020.1596. JAMA Psychiatry. 2020. PMID: 32609294 Free PMC article.

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